NATIONAL 

PREPAREDNESS

HHS Is Monitoring the 

Progress of Its 

Medical 

Countermeasure 

Efforts but Has Not 

Provided Previously 

Recommended 

Spending Estimates

Report to Congressional Committees

December 2013

GAO-14-90

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-90, a report to 

congressional committees

December 2013

NATIONAL PREPAREDNESS

HHS Is Monitoring the Progress of Its Medical 

Countermeasure Efforts but Has Not Provided 

Previously Recommended Spending Estimates

Why GAO Did This Study

Public health emergencies—the 2001 

anthrax attacks, the 2009 H1N1 

influenza pandemic, and others—have 

raised concerns about national 

vulnerability to threats from chemical, 

biological, radiological, and nuclear 

agents and new infectious diseases. 

There are some medical 

countermeasures—drugs, vaccines, 

and medical devices such as 

diagnostics—available to prevent, 

diagnose, or mitigate the public health 

impact of these agents and diseases, 

and development continues. HHS 

leads federal efforts to develop and 

procure countermeasures through the 

interagency PHEMCE. The Pandemic 

and All-Hazards Preparedness 

Reauthorization Act of 2013 mandated 

GAO to examine HHS’s and 

PHEMCE’s planning documents for 

medical countermeasure development 

and procurement needs and priorities. 

This report examines the extent to 

which HHS developed timelines, 

milestones, and spending estimates for 

PHEMCE priorities. GAO reviewed 

relevant laws; analyzed HHS’s 2012 

PHEMCE Strategy and Implementation 

Plan, HHS’s tools for tracking the 

implementation of PHEMCE activities, 

and data on countermeasure spending 

from fiscal years 2010 through 2013; 

and interviewed HHS officials.

What GAO Recommends

Although GAO is not making any new 

recommendations, based on prior work 

GAO is continuing to emphasize its 

2011 recommendation that HHS make 

more specific anticipated spending

information available to 

countermeasure developers. In its 

comments, HHS discussed its efforts 

to develop spending estimates.

What GAO Found

The Department of Health and Human Services (HHS) has established timelines 

and milestones for the 72 Public Health Emergency Medical Countermeasures 

Enterprise (PHEMCE) priorities—33 activities, 25 threat-based approaches, and 

14 capabilities—that HHS selected as key to fulfilling PHEMCE strategic goals. 

However, HHS has not made spending estimates for its medical countermeasure 

development or procurement priorities (priority countermeasures) publicly 

available. In the PHEMCE implementation plan, HHS has grouped the 72 

PHEMCE priorities into three time frames for completion—near-term (fiscal years 

2012 through 2014), midterm (fiscal years 2015 through 2017), and long-term 

(fiscal year 2018 and beyond). For 21 priority activities, 10 priority threat-based 

approaches, and 8 priority capabilities, HHS and PHEMCE have identified 

specific deliverables, each tied to a milestone or set of milestones that delineate 

the steps necessary to complete deliverables, and established more specific 

timelines for completion of deliverables and milestones. For example, HHS’s 

Office of the Assistant Secretary for Preparedness and Response (ASPR) is to 

lead the development of medical countermeasure requirements, which outline 

countermeasure quantity, type, and desired characteristics. Deliverables are the 

threat-specific requirements, such as for antidotes for mustard gas and other 

blister agents. Milestones for mustard gas antidote requirements reflect the 

PHEMCE activities to develop the requirements and the necessary approvals; 

the milestones are tied to interim timelines and culminate in approval by the 

ASPR Assistant Secretary by September 2013. HHS has not established specific 

deliverables, milestones, or timelines for the remaining 12 priority activities, 15 

priority threat-based approaches, and 6 priority capabilities other than their 

overall completion within the specified near- or midterm time frame. HHS 

monitors progress in completing deliverables and milestones for the priorities 

monthly, with PHEMCE partners meeting to discuss potential barriers to 

completing deliverables or meeting milestones and possible options to mitigate 

these barriers. As of September 2013 (the most recent information available), 

HHS reported that PHEMCE partners have completed 10 deliverables for the 72 

priorities, resulting in completion of 5 priorities. GAO did not examine the status 

of the priorities that did not have specific deliverables, timelines, and milestones.

HHS has developed spending estimates for priority countermeasures for internal 

planning purposes but has not made them publicly available. In 2011, GAO

recommended that HHS provide more specific anticipated spending information 

in an updated plan to assist with long-term planning. HHS’s 2012 plan contains 

information on how countermeasures may be funded, such as through advanced 

development funds, but does not include estimates of how much PHEMCE may 

spend to develop specific countermeasures. HHS officials said they are hesitant 

to provide estimates because they do not want to create the expectation that 

estimates would reflect final contract amounts. However, consistent with our prior 

recommendation and Pandemic and All-Hazards Preparedness Reauthorization 

Act requirements, HHS plans to include spending estimates in the next iteration 

of the plan, anticipated in September 2014, but has not determined the nature 

and format of the estimates that would be included. Providing estimates would 

allow HHS’s industry partners to suitably target research and development to 

fulfill countermeasure priorities, especially in tighter budget climates.

View GAO-14-90. For more information, 

contact Vijay A. D’Souza at (202) 512-7114 or 

dsouzav@gao.gov.
Page i GAO-14-90 HHS Medical Countermeasures

Letter 1 

Background 5

HHS Has Established Timelines and Milestones for Key PHEMCE 

Priorities but Has Not Yet Provided Previously Recommended 

Anticipated Spending Estimates for Priority Countermeasures 14

Concluding Observations 20

Agency Comments 20

Appendix I HHS Spending on Advanced Research, Development, and 

Procurement of Medical Countermeasures 22

Appendix II Comments from the Department of Health and Human Services 26

Appendix III GAO Contact and Staff Acknowledgments 29

Related GAO Products 30

Tables

Table 1: Public Health Emergency Medical Countermeasures 

Enterprise (PHEMCE) Strategic Goals and Examples of 

Priority Activities 10

Table 2: Public Health Emergency Medical Countermeasures 

Enterprise (PHEMCE) Medical Countermeasure 

Advanced Development and Procurement Priorities 

(Priority Countermeasures) 13

Table 3: Biomedical Advanced Research and Development 

Authority Spending on Contracts Dedicated to Chemical, 

Biological, Radiological, and Nuclear and Pandemic 

Influenza Medical Countermeasure Advanced Research 

and Development, Fiscal Year 2010 through Fiscal Year 

2013 24

Contents
Page ii GAO-14-90 HHS Medical Countermeasures

Table 4: Biomedical Advanced Research and Development 

Authority Spending on Contracts Dedicated to Pandemic 

Influenza Medical Countermeasure Procurement, Fiscal 

Year 2010 through Fiscal Year 2013 25

Table 5: Biomedical Advanced Research and Development 

Authority Spending on Contracts Dedicated to Chemical, 

Biological, Radiological, and Nuclear Medical 

Countermeasure That Include Both Advanced Research 

and Development and Procurement, Fiscal Year 2010 

through Fiscal Year 2013 25

Figures

Figure 1: Processes for Medical Countermeasure Development 

and Procurement 8

Figure 2: Percentage of Advanced Research, Development, and 

Procurement Spending by Medical Countermeasure 

Type, Fiscal Year 2010 through Fiscal Year 2013 23
Page iii GAO-14-90 HHS Medical Countermeasures

Abbreviations

ASPR Office of the Assistant Secretary for Preparedness 

 and Response

BARDA Biomedical Advanced Research and Development 

 Authority

CBRN chemical, biological, radiological, and nuclear

CDC Centers for Disease Control and Prevention

DHS Department of Homeland Security

FDA Food and Drug Administration

HHS Department of Health and Human Services

MTA material threat assessment

NIH National Institutes of Health

PAHPRA Pandemic and All-Hazards Preparedness Reauthorization

 Act of 2013

PHEMCE Public Health Emergency Medical Countermeasures 

 Enterprise

SNS Strategic National Stockpile

TRA terrorism risk assessment

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-14-90 HHS Medical Countermeasures

441 G St. N.W.

Washington, DC 20548

December 27, 2013

The Honorable Tom Harkin

Chairman

The Honorable Lamar Alexander

Ranking Member

Committee on Health, Education, Labor, and Pensions

United States Senate

The Honorable Fred Upton

Chairman

The Honorable Henry Waxman

Ranking Member

Committee on Energy and Commerce

House of Representatives

Public health emergencies in the new millennium—the 2001 anthrax 

attacks, the 2009 H1N1 influenza pandemic, the Middle East respiratory 

syndrome coronavirus currently circulating in Saudi Arabia and other 

countries, and others—continue to raise concern about our nation’s 

vulnerability to threats from chemical, biological, radiological, and nuclear 

(CBRN) agents and new or reemerging infectious diseases. Rapid 

diagnosis, treatment, and prevention may minimize the public health 

effects of a release of a CBRN agent or the spread of a new or 

reemerging infectious disease. There are some medical 

countermeasures—drugs, vaccines, and devices to diagnose, treat, 

prevent, or mitigate potential health effects of exposure—available for 

these agents and diseases. However, research and development to 

create usable countermeasures is a lengthy, complex, and expensive 

process that requires public and private investment. Since 2004, 

Congress has authorized over $8 billion for the procurement of medical 

countermeasures for use against CBRN agents.1

 

1

6 U.S.C. § 321j; 42 U.S.C. § 247d-6b(g)(1).

However, the general 

lack of a commercial market for medical countermeasures against these 

agents and diseases may reduce incentives for industry—pharmaceutical 

and medical device manufacturers—to invest millions of dollars to 

develop CBRN medical countermeasures instead of other products that 

may be more lucrative.
 

Page 2 GAO-14-90 HHS Medical Countermeasures

The Department of Health and Human Services (HHS) is the federal 

agency primarily responsible for identifying needed medical 

countermeasures to prevent or mitigate potential health effects from 

exposure to CBRN agents and new or reemerging infectious diseases 

and for engaging with industry to develop those countermeasures. In 

2006, HHS established the Public Health Emergency Medical 

Countermeasures Enterprise (PHEMCE), a federal interagency body 

whose partners include certain HHS agencies and offices, the 

Department of Homeland Security (DHS), the Department of Defense, 

and other federal agencies. PHEMCE is responsible for providing 

recommendations to the Secretary of Health and Human Services on 

medical countermeasure priorities and development and procurement 

activities. PHEMCE also coordinates the life cycle of medical 

countermeasure research and development from basic research, through 

advanced research and development, to procurement for the Strategic 

National Stockpile (SNS)—the national repository for medications, 

medical supplies, and equipment for use in a public health emergency—

and develops policies, plans, and guidance for the use of countermeasure 

products.

In October 2011, we reported on HHS’s and PHEMCE’s efforts to develop 

and procure priority medical countermeasures and found that some 

improvements were needed for HHS to effectively oversee these efforts.2

 

2

See GAO, National Preparedness: Improvements Needed for Acquiring Medical 

Countermeasures to Threats from Terrorism and Other Sources, 

For example, we found that HHS lacked an adequate strategy to monitor 

the implementation of recommendations from its 2010 PHEMCE review. 

We also found that HHS had not yet updated the first PHEMCE 

Implementation Plan for procuring CBRN countermeasure priorities, 

published in 2007, even though HHS had planned to update it biennially. 

We recommended that the department update the plan, include more 

specific information about anticipated spending, and strengthen its 

oversight of how HHS agencies and offices were implementing certain 

activities intended to enhance PHEMCE. HHS agreed with our overall 

recommendations but did not provide any comments specifically about its 

plans to include anticipated spending estimates in any implementation 

plan updates. We discuss the current status of this recommendation later 

GAO-12-121

(Washington, D.C.: Oct. 26, 2011).
 

Page 3 GAO-14-90 HHS Medical Countermeasures

in the report. In June 2012, HHS published the PHEMCE Strategy,3 and 

in December 2012 it published the PHEMCE Implementation Plan,4

The Pandemic and All-Hazards Preparedness Reauthorization Act of 

2013 (PAHPRA) requires GAO to examine HHS’s PHEMCE strategy and 

implementation plan, which lay out PHEMCE’s strategic goals and 

activities for achieving these goals and developing and procuring priority 

medical countermeasures.

which 

serves to update the 2007 implementation plan.

5

To determine the extent to which HHS has developed timelines, 

milestones, and anticipated spending estimates to achieve the PHEMCE 

priorities, we reviewed relevant laws to determine requirements for HHS 

to develop the PHEMCE Strategy and Implementation Plan and any 

required elements to be included in these documents. We obtained and 

analyzed HHS’s most recent PHEMCE planning documents, including its 

2012 PHEMCE Strategy and 2012 PHEMCE Implementation Plan, to 

identify PHEMCE priorities, and we reviewed the 72 items in the 

implementation plan that HHS selected as key priorities for fulfilling 

PHEMCE’s strategic goals within the next 5 years. We also analyzed 

these documents and other documents HHS uses to track the 

implementation of PHEMCE activities to identify any timelines, 

milestones, and anticipated spending estimates HHS may have 

established to achieve these priorities. We compared these documents to 

the Project Management Institute’s The Standard for Program 

Management—which calls for development of timelines, milestones, and 

cost estimates as program management leading practices—to determine 

whether HHS had appropriate controls in place to oversee the 

This report addresses the extent to which 

HHS has developed timelines, milestones, and anticipated spending 

estimates to achieve PHEMCE priorities laid out in these documents. We 

provide information on HHS’s spending on medical countermeasure 

development and procurement from fiscal year 2010 through fiscal year 

2013 in appendix I. 

 

3

Department of Health and Human Services, 2012 Public Health Emergency Medical 

Countermeasures Enterprise (PHEMCE) Strategy (Washington, D.C.: June 2012).

4

Department of Health and Human Services, Public Health Emergency Medical 

Countermeasures Enterprise (PHEMCE) Implementation Plan (Washington, D.C.: 

December 2012).

5

42 U.S.C. § 300hh-10(d)(3). 
 

Page 4 GAO-14-90 HHS Medical Countermeasures

implementation of PHEMCE activities.6

In addition, to provide information on HHS’s spending on medical 

countermeasure development and procurement in appendix I, we 

obtained and analyzed HHS data on its spending for medical 

countermeasure advanced research, development, and procurement from 

fiscal year 2010 through fiscal year 2013.

We also examined information on 

the progress PHEMCE participants had made in meeting timelines and 

milestones to achieve the priorities, based on HHS reporting from its 

tracking documents through September 2013, the most recent information 

available at the time of our review. We did not conduct further analysis of 

the progress that has been made because of the relatively short period 

from the publication of the implementation plan in December 2012 to the 

time we completed our review. We interviewed PHEMCE partners from 

HHS agencies and offices—including the Office of the Assistant Secretary 

for Preparedness and Response (ASPR), the Biomedical Advanced 

Research and Development Authority (BARDA), the National Institutes of 

Health (NIH), the Centers for Disease Control and Prevention (CDC), and 

the Food and Drug Administration (FDA)—to obtain information on HHS 

timelines, milestones, and spending estimates for PHEMCE priorities; 

how HHS tracks the progress of PHEMCE partners in implementing the 

PHEMCE priorities; and progress made to date.

7 We chose this period because 

we previously reported on HHS’s medical countermeasure spending from 

fiscal year 2007 through fiscal year 2010.8

We conducted this performance audit from May 2013 through December

2013 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

We obtained information from 

HHS and interviewed officials about how they ensure the accuracy of the 

funding information provided. We did not independently verify the 

spending information provided by HHS, but we determined, through 

interviews and reviews of supporting information, that the data we 

received from HHS were sufficiently reliable for our purposes.

 

6

See Project Management Institute, The Standard for Program Management, 3rd ed. 

(Newton Square, Pa.: 2013).

7

For the purposes of this report, we use spending to mean obligations. Generally, an 

obligation is a definite commitment that creates a legal liability of the government for the 

payment of goods and services ordered and received.

8

See GAO-12-121. 
 

Page 5 GAO-14-90 HHS Medical Countermeasures

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

Since 2004, Congress has authorized over $8 billion for medical 

countermeasure procurement. The Project BioShield Act of 2004 

authorized the appropriation of $5.6 billion from fiscal year 2004 through 

fiscal year 2013 for the Project BioShield Special Reserve Fund,9 and 

funds totaling this amount were appropriated.10 The act facilitated the 

creation of a government countermeasure market by authorizing the 

government to commit to making the Special Reserve Fund available to 

purchase certain medical countermeasures,11 including those 

countermeasures that may not be FDA-approved, cleared, or licensed.12

In 2013, PAHPRA authorized an additional $2.8 billion to be available 

from fiscal year 2014 through fiscal year 2018 for these activities,13

 

9

6 U.S.C. § 321j.

but 

funding has not yet been appropriated for these years. In addition to the 

10The Department of Homeland Security appropriations act for fiscal year 2004 

appropriated this amount. Pub. L. No. 108-90, 117 Stat. 1137, 1148 (2003).

116 U.S.C. § 321j; 42 U.S.C. §§ 247d-6b(c). The Project BioShield Act also authorizes the 

federal government to use specific contracting authorities to procure certain medical 

countermeasures for CBRN agents. 42 U.S.C. § 247d-6b(c)(7). The act allowed for the 

use of the Special Reserve Fund only for medical countermeasure procurement; however, 

since 2006, various appropriations acts have transferred $2.1 billion from the Special 

Reserve Fund, $1.9 billion of which was transferred for advanced research and 

development.

12Under federal law and FDA regulations, vaccines and other biologics are “licensed,” 

drugs are “approved,” and devices may either be “approved” or “cleared.” See 42 U.S.C. 

§ 262, 21 U.S.C. § 355, 21 U.S.C. §§ 360e, 360(k). The Special Reserve Fund may be 

used to acquire medical countermeasures that are reasonably expected to qualify for FDA 

approval, clearance, or licensure within a certain number of years. The Project BioShield 

Act initially stipulated expected FDA approval, clearance, or licensure within 8 years, and 

PAHPRA subsequently extended this period to 10 years. 42 U.S.C. § 247d6b(c)(1)(B)(i)(III)(bb). The Secretary of Health and Human Services may also authorize, 

under specified conditions, the temporary emergency use of products that have not yet 

received FDA approval, clearance, or licensure. 21 U.S.C. § 360bbb-3.

1342 U.S.C. § 247d-6b(g). PAHPRA provides that amounts appropriated pursuant to this 

section are authorized to remain available until September 30, 2019. PAHPRA also 

stipulates that HHS may use not more than 50 percent of the amounts authorized for the 

Special Reserve Fund for medical countermeasure advanced research and development.

Background
 

Page 6 GAO-14-90 HHS Medical Countermeasures

Special Reserve Fund, Congress has also made funding available 

through annual and supplemental appropriations to respond to influenza 

pandemics, including developing vaccines and other drugs.14

HHS is the primary federal department responsible for public health 

emergency planning and response, including medical countermeasure 

development, procurement, and distribution. HHS also coordinates with 

other federal departments, such as DHS, through PHEMCE.

Within HHS, several offices and agencies have specific responsibilities for 

public health preparedness and response.

• HHS’s ASPR leads PHEMCE and the federal medical and public 

health response to public health emergencies, including strategic 

planning, medical countermeasure prioritization, and support for 

developing, procuring, and planning for the effective use of medical 

countermeasures.

• Within ASPR, BARDA—established by the Pandemic and All-Hazards 

Preparedness Act of 200615—oversees and supports advanced 

development and procurement of some medical countermeasures into 

the SNS.16

• NIH conducts and funds basic and applied research and early 

development needed to develop new or enhanced medical 

countermeasures and related medical tools for CBRN and infectious 

disease threats.17

 

14See, for example, Pub. L. No. 111-32, 123 Stat. 1859, 1884-86 (2009).

1542 U.S.C. § 247d-7e(c). The act also gave BARDA the authority to make advance and 

milestone-based payments to vendors prior to product delivery to the SNS. 42 U.S.C. 

§ 247d-7e(c)(5)(C), (D).

16In the advanced research and development stage, potential medical countermeasures 

are further evaluated to demonstrate safety and effectiveness for preventing, diagnosing, 

or treating disease. Successful products are then available for development and 

procurement. BARDA also determines whether manufacturing, scale-up production, and 

licensing of countermeasures can be achieved in a timely and reliable manner.

17Basic, or early, research seeks to better understand CBRN agents and the response of 

the host organism to the agents through the study of the cellular and molecular biology of 

agents and hosts, their physiologic processes, and their genome sequences and 

structures. Applied, or translational, research builds on basic research by validating and 

testing concepts in practical settings to identify potential products. 

Federal Roles and 

Responsibilities Related to 

Medical Countermeasures
 

Page 7 GAO-14-90 HHS Medical Countermeasures

• CDC maintains the SNS, including purchasing commercially available 

products as necessary, and supports state and local public health 

departments’ efforts to detect and respond to public health 

emergencies, including providing guidance and recommendations for 

the mass dispensing and use of medical countermeasures from the 

SNS.

• FDA assesses the safety and effectiveness of medical 

countermeasures; regulates their development; approves, clears, or 

licenses them; and conducts postmarket surveillance as part of its 

overall role to assess the safety and effectiveness of medical 

products. FDA also provides technical assistance to help ensure that 

product development meets FDA’s regulatory requirements and 

provides technical support for the development of regulatory science

tools. FDA may authorize the emergency use of medical products that 

have not yet been approved, cleared, or licensed or were approved, 

cleared, or licensed only for other uses.

DHS develops material threat assessments (MTA), in coordination with 

HHS, to assess the threat posed by given CBRN agents or classes of 

agents and the potential number of human exposures in plausible, highconsequence scenarios. DHS uses the MTAs to determine which CBRN 

agents pose a material threat sufficient to affect national security and to 

provide HHS with a basis for determining needed countermeasures for 

those agents. DHS also develops terrorism risk assessments (TRA) to 

assess the relative risks posed by CBRN agents based on variable 

threats, vulnerabilities, and consequences.18

HHS’s PHEMCE is responsible for establishing civilian medical 

countermeasure priorities for CBRN and emerging infectious disease 

threats, including influenza; coordinating federal efforts to research, 

develop, and procure medical countermeasures to enhance 

preparedness and response for public health threats; and developing 

policies, plans, and guidance for the use of countermeasure products in a 

public health emergency. PHEMCE is composed of officials from ASPR, 

 

18For more information on DHS’s MTAs and TRAs, see GAO, National Preparedness: 

DHS and HHS Can Further Strengthen Coordination for Chemical, Biological, 

Radiological, and Nuclear Risk Assessments, GAO-11-606 (Washington, D.C.: June 21, 

2011); and Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS 

Should Establish More Specific Guidance for Their Use, GAO-12-272 (Washington, D.C.: 

Jan. 25, 2012).
 

Page 8 GAO-14-90 HHS Medical Countermeasures

including BARDA; CDC; FDA; NIH; and other federal departments, 

including the Departments of Agriculture, Defense, Homeland Security, 

and Veterans Affairs. HHS and PHEMCE establish federal medical 

countermeasure development and procurement priorities through a 

multistep process. This process includes assessing the threat posed by 

CBRN agents and the potential consequences they pose to public health, 

determining medical countermeasure requirements—the type of 

countermeasure (vaccines, drugs, or medical devices such as 

diagnostics), the amount needed, and characteristics of the 

countermeasures (such as formulations, dosing, and packaging)—for 

these agents, evaluating public health response capability, and 

developing and procuring countermeasures against these CBRN agents. 

(See fig. 1.)

Figure 1: Processes for Medical Countermeasure Development and Procurement

a

DHS collaborates with the Department of Health and Human Services (HHS) and other federal 

partners to identify threats.

b

In addition to approving, clearing, or licensing medical countermeasures, FDA works with 

researchers throughout the development stages to review safety and effectiveness test results and 

provide technical assistance to help ensure that product development meets FDA’s regulatory 

requirements.

The 2012 PHEMCE Strategy lays out the four PHEMCE strategic goals 

and their underlying objectives for building HHS’s countermeasure 

capabilities to respond to a public health emergency. The 2012 PHEMCE 

Implementation Plan updates the 2007 implementation plan and 

describes the activities that HHS and its interagency partners plan to 

conduct to achieve the four strategic goals and their associated 

objectives, the medical countermeasures HHS wants to develop and 

PHEMCE Strategy, 

Implementation Plan, and 

Priorities
 

Page 9 GAO-14-90 HHS Medical Countermeasures

procure, and the capabilities HHS wants to build to support 

countermeasure development and procurement. The plan also includes 

72 items that HHS selected as key priorities for fulfilling PHEMCE’s 

strategic goals within the next 5 years, which the agency placed into three 

categories. For the purposes of this report we refer to the items in these 

categories as “priority activities,” “priority threat-based approaches,” and 

“priority capabilities.”

• The 33 priority activities reflect activities that support PHEMCE’s 

overall mission and include pursuits such as developing systems to 

track countermeasure activities across all PHEMCE partners, 

enhancing national laboratory capabilities, and developing guidance 

documents and information for the public on using medical 

countermeasures in an emergency. (See table 1 for examples of 

PHEMCE priority activities by strategic goal.)
 

Page 10 GAO-14-90 HHS Medical Countermeasures

Table 1: Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategic Goals and Examples of Priority 

Activities

Strategic goal Example of priority activity

1. Identify, create, develop, 

manufacture, and procure critical 

medical countermeasures

Implement tools that track progress of medical countermeasure development and 

procurement contracts across all PHEMCE partners to further enable coordinated 

planning and management

Formalize roles, responsibilities, policies, and procedures for conducting the next 

generation of material threat assessments and terrorism risk assessments

Establish a network of clinical research organizations to assist the Biomedical Advanced 

Research and Development Authority in conducting phase I through IV clinical trials of 

investigational medical countermeasuresa

2. Establish and communicate clear 

regulatory pathways to facilitate 

medical countermeasure 

development and use

Establish a multidisciplinary action team to provide regulatory support for the development 

of multiplex diagnostic devicesb

Establish a multidisciplinary action team to facilitate the development and regulatory 

review of radiation biodosimetry devices and provide regulatory support for the 

performance of these devicesc

Establish a program to link FDA scientists with external partners to pursue cutting-edge 

regulatory science projects

3. Develop logistics and operational 

plans for optimized use of medical 

countermeasures at all levels of 

response

Establish a process to validate laboratory methods and enhance national capacity to 

rapidly test clinical specimens and determine who has been exposed to biological agents

Develop decision-making and planning guidance for medical countermeasure dispensing 

models to meet the diverse needs of communities

Develop a comprehensive action plan for monitoring the safety and clinical benefit of 

medical countermeasures during public health emergencies

4. Address medical countermeasure 

gaps for all sectors of the U.S. civilian 

population

Provide clinicians with dosing and use guidance for administering stockpiled medical 

countermeasures to pediatric populations in public health emergencies

Ensure that public health and medical information distributed during public health 

emergencies is delivered in a manner that takes into account the range of communication 

and other needs of the intended audience, including at-risk individualsd

Integrate operational requirements, considerations, resource, and action items for 

pediatric and other at-risk populations into HHS emergency response playbookse

Source: GAO analysis of Department of Health and Human Services (HHS) information.

a

Manufacturers conduct clinical trials in human volunteers in five phases (0 through IV) to determine 

whether candidate countermeasures are effective and safe.

b

Multiplex diagnostic devices are those that allow for the testing of multiple agents using the same 

technology.

c

Biodosimetry devices and bioassays are tools that determine the level of radiation in the body and 

the type of radiological isotope to which an individual has been exposed.

d

HHS recognizes at-risk individuals to include children, senior citizens, and pregnant women, in 

addition to those individuals who have additional communication, medical care, and other needs or 

who may need additional assistance in a public health emergency as a result of disability, 

transportation needs, limited or no English proficiency, or other reasons.

e

HHS Office of the Assistant Secretary for Preparedness and Response playbooks are intended to 

provide strategic guidance for HHS’s medical and public health response under the National 

Response Framework. The playbooks outline key options and recommended actions to support the 

HHS Secretary in directing and coordinating HHS’s response to disasters and public health 

emergencies.
 

Page 11 GAO-14-90 HHS Medical Countermeasures

• In addition to the 33 priority activities, the 25 items identified as 

priorities for threat-based approaches are intended to directly address 

threats such as anthrax or smallpox. These priorities include pursuits 

such as publishing updated clinical guidance for anthrax

countermeasures; developing and qualifying with FDA animal models 

to test the safety and efficacy of medical countermeasures for certain 

biological, radiological, and nuclear threats;19

• The remaining 14 items identified as priority capabilities reflect what 

HHS refers to as crosscutting capabilities. The priority capabilities are 

a mix of programs or technological applications that may, for example, 

support the development of countermeasures for a range of existing 

CBRN threats or for any new threats that may emerge in the future, or 

build infrastructure to provide countermeasure developers assistance 

with advanced development and manufacturing services. The priority 

capabilities include such pursuits as initiating a research program to 

fill gaps in knowledge in the area of patient decontamination in a 

chemical incident and establishing a network of facilities to support 

the filling and finishing of vaccines and other countermeasures.

and developing new 

plans for the distribution and dispensing of pandemic influenza 

antivirals.

20

In addition to the 72 items HHS selected as key priorities for fulfilling 

PHEMCE’s strategic goals, the implementation plan also identifies the 

medical countermeasures that constitute HHS’s priorities for development 

and procurement to fulfill strategic goal 1, which we refer to as “priority 

countermeasures” for the purposes of this report. (See table 2.) Many of 

 

19Under the Animal Rule, in selected circumstances, FDA may grant marketing approval 

of CBRN countermeasures based on adequate and well-controlled animal studies, using 

animal models, when it is neither ethical nor feasible to conduct human efficacy studies, 

provided that the results of those studies establish that the drug or biological product is 

reasonably likely to produce clinical benefit in humans. 21 C.F.R. §§ 314.600-.650, 

601.90-.95. FDA developed a process to qualify animal models and encourages 

countermeasure developers to qualify these models when the model has the potential to 

be used for licensure or approval of multiple medical countermeasures. FDA’s animal 

model qualification process uses analytically valid measurements of the model, which can 

be relied upon to have a specific use in drug development. FDA makes information on 

qualified animal models public; countermeasure developers may then use the qualified 

animal model within its defined purpose without requiring FDA to reconfirm the model’s 

utility, which may help expedite the approval of new drug applications.

20The filling and finishing of countermeasures refers to the process by which individual 

drugs are packaged for use, such as in vials and syringes, and includes labeling, patient 

instructions, outside packaging, transport, and promotional materials.
 

Page 12 GAO-14-90 HHS Medical Countermeasures

the threat-specific countermeasures for which PHEMCE set procurement 

priorities in 2007 continue to be priorities for development and 

procurement in the 2012 plan, such as anthrax vaccine, smallpox 

antivirals, chemical agent antidotes, and diagnostic devices for 

radiological and nuclear agents.21 The 2012 plan also includes pandemic 

influenza countermeasures and nonpharmaceutical countermeasures, 

such as ventilators, as priorities, whereas the 2007 plan focused on 

CBRN medical countermeasures only.

 

21In addition to the priority countermeasures, the 2012 plan also identifies other medical 

countermeasure development activities, including improving the delivery systems of 

countermeasures already in the SNS, evaluating existing commercial drugs for use in 

public health emergencies, and seeking FDA approval or clearance for certain 

countermeasures in the SNS.
 

Page 13 GAO-14-90 HHS Medical Countermeasures

Table 2: Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Medical Countermeasure Advanced 

Development and Procurement Priorities (Priority Countermeasures)

Medical countermeasure Advanced development prioritya Procurement priorityb

Anthrax antitoxin x x 

Anthrax vaccine x x 

Botulism antitoxin x 

Broad spectrum antimicrobialsc x x 

Chemical decontamination products x 

Cyanide antidote x x 

Diagnostics for biological agents x 

Nerve agent antidote x x 

Nuclear agents, gastrointestinal, skin, and lung therapeutics x x 

Nuclear agents, hematopoietic therapeutics x x 

Nuclear agents, thermal burn therapeutics x x 

Pandemic influenza antivirals x x 

Pandemic influenza diagnostics x 

Pandemic and prepandemic influenza vaccine x 

Radiological agents, decorporation and blocking agents x x 

Radiological and nuclear bioassay/biodosimetryd (diagnostics) x x 

Respiratory protective devicese x x 

Smallpox antivirals x x 

Smallpox vaccine x x 

Ventilators x x 

Viral hemorrhagic fever antivirals x 

Volatile nerve agent diagnostics x 

Source: Department of Health and Human Services (HHS). 

a

HHS’s and PHEMCE’s medical countermeasure advanced development priorities include new 

products currently in development and enhancements to current products in the Strategic National 

Stockpile.

b

For the purposes of this report, we consider HHS’s and PHEMCE’s medical countermeasure 

procurement priorities to include those countermeasures that HHS plans to purchase for the SNS 

through fiscal year 2017, dependent upon the availability of funds.

c

Broad spectrum antimicrobials include those for anthrax, plague, tularemia, typhus, and secondary 

infections from pandemic influenza and exposure to radiological and nuclear agents.

d

Biodosimetry devices and bioassays are tools that determine the level of radiation in the body and 

the type of radiological isotope to which an individual has been exposed.

e

Respiratory protective devices include items such as N95 respirators, which are designed to prevent 

the wearer from breathing in at least 95 percent of airborne particles, and surgical masks.
 

Page 14 GAO-14-90 HHS Medical Countermeasures

HHS has established timelines and milestones for the 72 priority 

activities, threat-based approaches, and capabilities identified in the 2012 

PHEMCE Implementation Plan as key to fulfilling PHEMCE’s strategic 

goals. However, while HHS has developed spending estimates for its 

priority medical countermeasures for internal planning purposes, it has 

not made these estimates publicly available, as we previously 

recommended in 2011.

HHS has established timelines and milestones for the 72 items it selected 

as key priorities for fulfilling PHEMCE’s strategic goals. Leading practices 

for program management call for establishing time frames and milestones 

as part of a plan to ensure that organizations achieve intended results.22

HHS has also identified deliverables and milestones for some of the 

priority activities, threat-based approaches, and capabilities, and 

assigned them more specific timelines. For 21 of the 33 priority activities, 

10 of the 25 priority threat-based approaches, and 8 of the 14 priority 

capabilities, HHS and the PHEMCE agency or office responsible for 

carrying out the activity have identified specific deliverables intended to 

complete them. PHEMCE partners have tied each deliverable to a 

specific milestone or set of milestones, which delineate the steps 

In the implementation plan, HHS has assigned each of the 33 priority 

activities, the 25 priority threat-based approaches, and the 14 priority 

capabilities to one of three time frames for completion—near-term (fiscal 

years 2012 through 2014), midterm (fiscal years 2015 through 2017), and 

long-term (fiscal year 2018 and beyond). In addition, HHS has placed 

PHEMCE’s priority countermeasures into these time frames. All but 2 of 

the 33 priority activities, and all of the priority threat-based approaches 

and capabilities, are slated for completion in either the near term or the 

midterm.

 

22The Project Management Institute, The Standard for Program Management, 3rd ed.

HHS Has Established 

Timelines and 

Milestones for Key 

PHEMCE Priorities 

but Has Not Yet 

Provided Previously 

Recommended 

Anticipated Spending 

Estimates for Priority 

Countermeasures

HHS Has Established 

Timelines and Milestones 

for Key PHEMCE Priorities
 

Page 15 GAO-14-90 HHS Medical Countermeasures

necessary to complete the deliverable. In addition, the deliverables and 

milestones may have more specific timelines, such as an actual month or 

year of expected completion within the broader multiyear near- or 

midterm time frame. Examples of deliverables, milestones, and more 

specific timelines for PHEMCE priorities include the following:

• For the priority activity that states that ASPR is to lead PHEMCE in 

developing or updating medical countermeasure requirements for 

certain CBRN threats by the end of fiscal year 2014, ASPR has 

identified the requirements for each specific threat—such as 

requirements for countermeasures for mustard gas and other blister 

agents—as the individual deliverables for this activity. The blister 

agents requirement deliverable has four associated milestones that 

reflect the various activities of a PHEMCE working group to develop 

the requirements and the levels of PHEMCE and HHS approval 

needed, culminating in the approval by the ASPR Assistant Secretary 

by September 2013. 

• For the priority threat-based approach of qualifying animal models for 

biological threats, the deliverable is FDA qualification of the animal 

model, and the three milestones are the development of animal 

models for anthrax, plague, and tularemia in fiscal year 2015.23

• For the priority capability of initiating funding for the development of 

diagnostic systems for biological and chemical threat agents, and 

systems to identify and characterize unknown threats, the deliverable 

is NIH’s awarding of funds to eligible applicants; the set of milestones 

for this deliverable are obtaining NIH approval to publish a solicitation 

for proposals for development of the diagnostics, publishing the 

solicitation in July 2013, and making awards in fiscal year 2014. NIH 

also plans to award additional funds in fiscal year 2015 for the 

development of multiplex diagnostic platforms for multiple threats.24

 

23In commenting on a copy of our report, FDA officials stated that in contrast to the 

targeted fiscal year 2015 completion date for these milestones, as indicated in HHS 

tracking information, they expect the completion date for the milestones for this priority to 

occur sometime in the midterm (fiscal year 2015 through fiscal year 2017). In addition, 

although the PHEMCE Implementation Plan and HHS’s tracking information for these 

priorities states that the animal models will be for anthrax, plague, and tularemia, FDA 

officials stated that, while these were the most likely threats for the models, they were not 

definite.

24Multiplex diagnostic platforms are those that allow for the testing of multiple agents 

using the same technology.
 

Page 16 GAO-14-90 HHS Medical Countermeasures

• For the priority countermeasures, HHS officials told us that the 

department includes specific milestones in the contracts it awards to 

developers; these milestones reflect the expected course for research 

and development, such as holding and completing clinical trials to test 

the efficacy of a countermeasure or submitting inventory and storage 

plans, and have associated completion dates.

For the remaining 12 priority activities, 15 priority threat-based 

approaches, and 6 priority capabilities, HHS has not established specific 

deliverables with milestones and timelines other than the overall 

completion of the priority within the specified near- or midterm time frame. 

HHS officials told us that some activities do not have specific timelines 

because HHS considers them to be ongoing activities that PHEMCE 

conducts regularly. For example, at least every 18 months, ASPR 

conducts formal reviews across participating PHEMCE agencies of 

medical countermeasure portfolios for specific threats in order to monitor 

progress in developing and procuring medical countermeasures for those 

threats, identify remaining gaps and challenges to developing and 

procuring countermeasures, and develop potential solutions. For activities 

in the implementation plan that are slated for completion in the long term, 

HHS officials said that they intend to develop more specific timelines as 

the near- and midterm activities are completed.

ASPR tracks the progress of participating PHEMCE partners in 

implementing the priority activities, threat-based approaches, and 

capabilities by holding monthly meetings25 to collect information on 

progress.26 According to HHS officials, during these monthly meetings, 

PHEMCE participants discuss their progress in completing deliverables, 

potential barriers to completion, and any options to help mitigate these 

barriers.27

 

25ASPR holds separate monthly meetings for the CBRN-related initiatives and the 

pandemic-influenza-related initiatives.

ASPR officials told us they rely on the PHEMCE partner 

26ASPR also tracks the progress of PHEMCE partners in carrying out other initiatives 

identified in the 2012 PHEMCE implementation plan; we did not examine those initiatives 

for this report because HHS did not identify them in the implementation plan as key to 

fulfilling PHEMCE’s strategic goals in the near and midterm.

27HHS officials told us that for some priorities that are ongoing, such as development or 

procurement of specific priority countermeasures, ASPR may collect updates less 

frequently. For example, for priority countermeasures, ASPR does not track operational 

activities such as the manufacturing of a specific countermeasure on a monthly basis but 

does ask for periodic updates.
 

Page 17 GAO-14-90 HHS Medical Countermeasures

responsible for the activity to have adequate project management 

controls in place to determine the amount of progress that the partner 

agency has made. If an agency anticipates delays in or barriers to 

completing and meeting certain milestones, ASPR officials may assist in 

identifying additional support within PHEMCE partner agencies or within 

other federal agencies. For example, HHS officials told us that for one 

priority activity’s deliverable—developing requirements for anthrax 

antitoxins—CDC and FDA officials differed in their professional opinions 

on guidance for clinicians to administer the drug. PHEMCE senior 

management worked with the agencies to develop consensus wording for 

the guidance document to complete that deliverable. ASPR officials told 

us that they enter information collected in the meetings into a 

spreadsheet that contains descriptions of the PHEMCE priority activities, 

threat-based approaches, and capabilities; their associated deliverables, 

milestones, and timelines; and information on current progress, barriers to 

completion, and mitigation options.28 ASPR follows up with PHEMCE 

partners after the meetings to obtain any additional information, if 

necessary. ASPR distributes the finalized spreadsheet to PHEMCE 

partners about 1 week in advance of the next monthly meeting for them to 

use as reference for that meeting. ASPR officials told us they developed 

the tracking spreadsheet in response to the recommendation in our 2011 

report that HHS develop a written strategy to monitor the implementation 

of recommendations from HHS’s 2010 PHEMCE review and incorporated 

the PHEMCE priorities into the spreadsheet when HHS updated the 

implementation plan.29

 

28We identified the deliverables, timelines, and milestones for the 21 priority activities, 10 

priority threat-based approaches, and 8 priority capabilities from the tracking tool HHS 

uses to assess the implementation of PHEMCE initiatives. For the remaining 12 priority 

activities, 15 threat-based approaches, and 8 capabilities, HHS is indirectly tracking the 

progress of some of them by linking them to other activities, threat-based approaches, and 

capabilities it is tracking so that their progress may be reflected in another priority. We did 

not examine the status of the priorities that HHS is not actively tracking.

29GAO-12-121. 
 

Page 18 GAO-14-90 HHS Medical Countermeasures

At the completion of our review, PHEMCE was halfway through its nearterm period of fiscal year 2012 through fiscal year 2014. As of September 

2013 (the most recent information available):30

• PHEMCE partners reported completing five deliverables for the 21 

priority activities. For example, for the priority activity that specifies 

that HHS, DHS, and other federal partners are to formalize roles, 

responsibilities, policies, and procedures for conducting the next 

generation of MTAs and TRAs, HHS and DHS completed one of two 

deliverables by developing and cosigning a strategic implementation 

plan to conduct MTAs.31

• PHEMCE partners reported completing three deliverables for the 10 

priority threat-based approaches. For example, for one of the threatbased approaches, PHEMCE partners report completing the sole 

deliverable of developing guidance that establishes the order in which 

different groups of affected individuals would receive anthrax 

vaccination in a public health emergency. The completion of the three 

deliverables resulted in the completion of three priority threat-based 

approaches.32

• PHEMCE partners reported completing two deliverables for the eight 

priority capabilities. For example, for one of the priority capabilities, 

PHEMCE partners have reported completing the sole deliverable that 

specifies that BARDA will initiate a research program to address 

knowledge gaps in chemical decontamination of exposed individuals 

by awarding a contract to a university to gather data and develop 

decontamination procedures. The completion of the two deliverables 

resulted in the completion of two priority capabilities.33

 

30In addition to completing deliverables for certain PHEMCE priorities, PHEMCE partners 

also report partial progress for other deliverables for the priority activities, approaches, 

and capabilities. For example, 3 of the 10 priority threat-based approaches with a sole 

deliverable were 50 percent or more complete.

31Of the 21 priority activities with deliverables and milestones, 13 had a single deliverable 

and the remaining 8 had multiple deliverables.

32All 10 priority threat-based approaches had a single deliverable.

33Seven of the priority capabilities had a single deliverable, and one had multiple 

deliverables.
 

Page 19 GAO-14-90 HHS Medical Countermeasures

HHS has not provided publicly available spending estimates for research, 

development, or procurement for the countermeasures it identified as 

priorities in the 2012 implementation plan. We previously recommended 

that HHS provide more specific information on anticipated 

countermeasure spending when it updated its 2007 plan. Additionally, 

PAHPRA directs HHS to include anticipated funding allocations for each 

countermeasure priority in the PHEMCE strategy and implementation 

plan.34 The implementation plan contains information on the source of the 

funds for research, development, and procurement, such as the Special 

Reserve Fund. However, the plan does not include any estimates of how 

much of these funds HHS may spend to develop or procure specific 

priority countermeasures. HHS officials told us that while PHEMCE has 

developed spending estimates for internal planning, they are hesitant to 

provide these estimates to manufacturers because they do not want to 

create the expectation that the estimates would reflect any final contract 

amounts. In addition, anticipated spending estimates for future years may 

be unreliable because, according to HHS officials, the Special Reserve 

Fund will be appropriated annually after fiscal year 2014, as opposed to 

the fiscal year 2004 appropriation, which appropriated funds for a 10-year 

period.35 Additionally, officials stated that because HHS published the 

PHEMCE Implementation Plan prior to the passage of PAHPRA, the 

department did not include any spending estimates in the plan because it 

was unaware that PAHPRA would include that requirement. HHS officials 

said that they plan to include estimates in the next iteration of the plan, 

which they anticipate publishing in September 2014, based on the time 

frames laid out in PAHPRA. However, the nature and format of the 

spending estimates that would be included in the plan had not been 

determined. As we stated in our previous recommendation, information 

on anticipated spending would allow HHS’s industry partners to suitably 

target research and development to fulfill PHEMCE’s countermeasure 

priorities, especially in tighter budget climates.36

 

3442 U.S.C. § 300hh-10(d)(2)(D)(ii). 

While HHS officials 

expressed concerns regarding sharing internal spending estimates and 

the short-term nature of annual appropriations, these concerns could be 

addressed by agency communications with manufacturers when 

providing the spending estimates to make clear that spending estimates 

35Pub. L. No. 108-90, 117 Stat. 1137, 1148 (2003).

36GAO-12-121. 

HHS Has Not Provided 

Previously Recommended 

Spending Estimates for 

Priority Countermeasures
 

Page 20 GAO-14-90 HHS Medical Countermeasures

may not reflect final contract amounts, which depend on enacted 

appropriations levels, among other factors.

Developing and procuring medical countermeasures is a complex 

process that requires engagement across the federal government and 

with countermeasure developers in private industry. HHS has 

strengthened PHEMCE planning and oversight and has made progress in 

developing and procuring some medical countermeasures. However, 

given its almost 10-year efforts and the continuing lack of available 

countermeasures to fulfill PHEMCE’s many priorities, HHS would benefit 

from sharing information on its anticipated spending estimates with 

industry, to assist countermeasure developers with long-term business 

planning. PAHPRA’s requirement for HHS to include spending estimates 

for each medical countermeasure priority in future PHEMCE 

implementation plans is consistent with our 2011 recommendation. HHS’s 

plans to include more specific spending estimates in future plan updates 

could help implement both this requirement and our 2011 

recommendation, provided the department makes meaningful estimates 

of spending for countermeasure research, development, and procurement 

available to industry. These estimates—or ranges of estimates—will 

provide HHS’s industry partners with more transparency on anticipated 

returns on investment in the face of competing priorities for developing 

other drugs with a commercial market. We believe the value of making 

this information available outweighs HHS’s concerns, especially those 

related to uncertainty over future appropriations; anticipated 

countermeasure spending would provide industry with the information it 

needs to determine whether and how to suitably target their research and 

development programs in tight budget climates.

We provided a draft of this report to HHS, and its comments are reprinted 

in appendix II. In its comments, HHS acknowledged the effort we have 

taken to document HHS’s tracking processes for the activities in the 2012 

PHEMCE Implementation Plan. HHS commented that the 72 activities we 

focused on in this review—which were described in the implementation 

plan as key to HHS’s efforts in the near and midterm—were a subset of 

255 near- and midterm activities delineated in the implementation plan 

and that these 72 items were meant to be an illustrative but not 

comprehensive list of priorities. Further, HHS stated that it considered all 

255 near- and midterm activities as priorities. HHS provided information 

on its efforts to track its progress on the remainder of these items that we 

did not discuss in the report and to establish deliverables and interim 

Concluding 

Observations

Agency Comments
 

Page 21 GAO-14-90 HHS Medical Countermeasures

milestones for the activities slated for the midterm (fiscal years 2015 

through 2017) as that period approaches. Finally, HHS provided 

information on its efforts to quantify its resource needs and provide more 

transparent anticipated spending information for its medical 

countermeasure development efforts while maintaining the integrity of the 

federal contracting process. HHS stated that it is working to find a 

compromise solution that will provide this transparency in light of statutory

requirements and GAO’s 2011 recommendation. HHS also provided 

technical comments, which we incorporated as appropriate.

We are sending copies of this report to the Secretary of Health and 

Human Services. In addition, the report is available at no charge on the 

GAO website at http://www.gao.gov. 

If you or your staffs have any questions about this report, please contact 

me at (202) 512-7114 or dsouzav@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on 

the last page of this report. GAO staff who made key contributions to this 

report are listed in appendix III.

Vijay A. D’Souza

Acting Director, Health Care
Appendix I: HHS Spending on Advanced 

Research, Development, and Procurement of 

Medical Countermeasures

Page 22 GAO-14-90 HHS Medical Countermeasures

The Department of Health and Human Services (HHS) spent 

approximately $3.6 billion1 in advanced research, development, and 

procurement of chemical, biological, radiological, and nuclear (CBRN) 

and pandemic influenza medical countermeasures from fiscal year 2010 

through fiscal year 2013.2 Of this amount, HHS spent 30 percent for 

countermeasures against influenza, 20 percent for smallpox

countermeasures, and 19 percent for anthrax countermeasures. (See 

fig. 2.) The spending on influenza countermeasures reflects, in part, 

HHS’s response to the 2009 H1N1 influenza pandemic using annual and 

supplemental funds appropriated for that response.3

 

1

For purposes of this report, we use spent to mean obligated. Generally, an obligation is a 

definite commitment that creates a legal liability of the government for the payment of 

goods and services ordered and received.

2

In the advanced research and development stage, potential medical countermeasures

are further evaluated to demonstrate safety and effectiveness for preventing, diagnosing, 

or treating disease. Successful products are then available for development and 

procurement.

3

The Supplemental Appropriations Act, 2009, provided nearly $1.9 billion in supplemental 

appropriations to respond to the H1N1 pandemic and an additional $5.8 billion that were 

available for obligation only in the amounts designated by the President in a notice to 

Congress as emergency funds to address critical needs related to emerging influenza 

viruses. Pub. L. No. 111-32, 123 Stat. 1859, 1884-85.

Appendix I: HHS Spending on Advanced 

Research, Development, and Procurement 

of Medical Countermeasures
Appendix I: HHS Spending on Advanced 

Research, Development, and Procurement of 

Medical Countermeasures

Page 23 GAO-14-90 HHS Medical Countermeasures

Figure 2: Percentage of Advanced Research, Development, and Procurement 

Spending by Medical Countermeasure Type, Fiscal Year 2010 through Fiscal Year 

2013

Note: HHS spent a total of $3.6 billion in medical countermeasure research, development, and 

procurement. For the purposes of this report, we use spent to mean obligated.

Of HHS’s total medical countermeasure spending of $3.6 billion, from 

fiscal year 2010 through fiscal year 2013, HHS spent almost $2.1 billion 

on contracts dedicated to advanced research and development, of which 

HHS’s Biomedical Advanced Research and Development Authority 

(BARDA) spent nearly $700 million (almost 34 percent) for influenza 

antivirals, diagnostics, and vaccines. (See table 3.) Of the remaining 

$1.5 billion, HHS spent nearly $403 million on contracts dedicated to the 

procurement of pandemic influenza antivirals and vaccines. (See table 4.) 

BARDA also spent almost $1.2 billion on contracts dedicated to both 

advanced research and development and procurement of CBRN medical 

countermeasures. (See table 5.) In addition to the contracts that have 

already been awarded, HHS issues annual announcements for additional 

funding opportunities in the areas of advanced research and development 

of CBRN medical countermeasures; advanced development of medical 

countermeasures for pandemic influenza; and innovative science and 

technology platforms for medical countermeasure development. The 
Appendix I: HHS Spending on Advanced 

Research, Development, and Procurement of 

Medical Countermeasures

Page 24 GAO-14-90 HHS Medical Countermeasures

announcements state anticipated funding for the overall program. For 

example, the announcement for CBRN countermeasure advanced 

research and development states that anticipated funding for the overall 

effort—not per award—ranges from an estimated $2 million to an 

estimated $415 million, subject to congressional appropriations, and does 

not reflect a contractual obligation for funding.

Table 3: Biomedical Advanced Research and Development Authority Spending on Contracts Dedicated to Chemical, 

Biological, Radiological, and Nuclear and Pandemic Influenza Medical Countermeasure Advanced Research and 

Development, Fiscal Year 2010 through Fiscal Year 2013

Medical countermeasure

Fiscal year 2010 

spending

Fiscal year 2011 

spending

Fiscal year 2012 

spending

Fiscal year 2013 

spending Total

Animal model development $0 $4,553,869 $36,976,777 $25,110,914 $66,641,560

Anthrax therapeutics 43,378,000 27,395,213 65,010,124 25,930,925 $161,714,262

Anthrax Vaccines 115,752,134 17,792,675 72,653,968 24,646,955 $230,845,732

Biodosimetry and biodiagnostics 

medical countermeasures 1,934,605 43,311,987 59,995,715 30,179,501 $135,421,808

Botulism 0 61,455,464 0 0 $61,455,464

Broad spectrum antimicrobials 27,559,110 39,478,000 (7,898,701)a 152,131,767 $ 211,270,175

Chemical medical 

countermeasures 2,100,000 15,603,816 5,975,494 5,678,348 $29,357,658

Influenza antivirals 0 295,109,349 28,379,502 44,092,454 $367,581,305

Influenza diagnostics 3,452,940 15,070,000 3,061,000 6,174,090 $27,758,030

Influenza vaccines 1,015 269,833,512 3,045 31,959,217 $301,796,789

Innovation 40,921,483 12,099,068 2,503,538 6,820,532 $62,344,621

Radiological and nuclear medical 

countermeasures 42,617,799 89,044,223 81,053,199 95,731,031 $308,446,252

Smallpox medical countermeasures 11,297,562 75,622,527 10,008,737 7,285,322 $104,214,148

Ventilators 2,600,000 0 0 0 $2,600,000

Total $291,614,648 $966,369,703 $357,722,398 $455,741,055 $2,071,447,804

Source: GAO analysis of Department of Health and Human Services (HHS) data.

Note: Totals may not add due to rounding.

a

In fiscal year 2012, HHS terminated a contract, which resulted in the deobligation of funds that had 

been obligated in the prior fiscal year.
Appendix I: HHS Spending on Advanced 

Research, Development, and Procurement of 

Medical Countermeasures

Page 25 GAO-14-90 HHS Medical Countermeasures

Table 4: Biomedical Advanced Research and Development Authority Spending on Contracts Dedicated to Pandemic Influenza 

Medical Countermeasure Procurement, Fiscal Year 2010 through Fiscal Year 2013 

Medical 

countermeasure

Fiscal year 2010 

spending

Fiscal year 2011 

spending

Fiscal year 2012 

spending

Fiscal year 2013 

spending Total

Influenza antivirals $27,591,014 $0 $0 $0 $27,591,014

Influenza vaccines 134,249,059 18,875,394 55,389,975 166,445,837 $374,960,263

Total $161,840,073 $18,875,394 $55,389,975 $166,445,837 $402,551,277

Source: GAO analysis of Department of Health and Human Services (HHS) data.

Note: Totals may not add due to rounding.

Table 5: Biomedical Advanced Research and Development Authority Spending on Contracts Dedicated to Chemical, 

Biological, Radiological, and Nuclear Medical Countermeasure That Include Both Advanced Research and Development and 

Procurement, Fiscal Year 2010 through Fiscal Year 2013

Medical countermeasure

Fiscal year 2010

spending

Fiscal year 2011 

spending

Fiscal year 2012 

spending

Fiscal year 2013 

spending Total

Anthrax Therapeutics $0 $8,000,000 $16,591,540 $261,869,865 $286,461,405

Chemical medical countermeasures 0 0 0 60,790,629 $60,790,629

Radiological and nuclear medical 

countermeasures 0 0- 0 194,655,775 $194,655,775

Smallpox medical countermeasures 0 440,687,626 36,587,261 137,926,401 $615,201,288

Total $0 $448,687,626 $53,178,801 $655,242,671 $1,157,109,098

Source: GAO analysis of Department of Health and Human Services (HHS) data.

Note: Totals may not add due to rounding.
Appendix II: Comments from the Department 

of Health and Human Services

Page 26 GAO-14-90 HHS Medical Countermeasures

Appendix II: Comments from the Department 

of Health and Human Services
Appendix II: Comments from the Department 

of Health and Human Services

Page 27 GAO-14-90 HHS Medical Countermeasures
Appendix II: Comments from the Department 

of Health and Human Services

Page 28 GAO-14-90 HHS Medical Countermeasures
Appendix III: GAO Contact and Staff 

Acknowledgments

Page 29 GAO-14-90 HHS Medical Countermeasures

Vijay A. D’Souza, (202) 512-7114 or dsouzav@gao.gov

In addition to the contact named above, Karen Doran, Assistant 

Director; Shana R. Deitch; Carolyn Feis Korman; Tracey King; and 

Roseanne Price made significant contributions to this report.

Appendix III: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments
Related GAO Products

Page 30 GAO-14-90 HHS Medical Countermeasures

National Preparedness: Efforts to Address the Medical Needs of Children 

in a Chemical, Biological, Radiological, or Nuclear Incident. GAO-13-438. 

Washington, D.C.: April 30, 2013.

National Preparedness: Improvements Needed for Measuring Awardee 

Performance in Meeting Medical and Public Health Preparedness Goals. 

GAO-13-278. Washington, D.C.: March 22, 2013.

High-Containment Laboratories: Assessment of the Nation’s Need Is 

Missing. GAO-13-466R. Washington, D.C.: February 25, 2013.

National Preparedness: Countermeasures for Thermal Burns. 

GAO-12-304R. Washington, D.C.: February 22, 2012.

Chemical, Biological, Radiological, and Nuclear Risk Assessments: DHS 

Should Establish More Specific Guidance for Their Use. GAO-12-272. 

Washington, D.C.: January 25, 2012.

National Preparedness: Improvements Needed for Acquiring Medical 

Countermeasures to Threats from Terrorism and Other Sources. 

GAO-12-121. Washington, D.C.: October 26, 2011.

Influenza Pandemic: Lessons from the H1N1 Pandemic Should Be 

Incorporated into Future Planning. GAO-11-632. Washington, D.C.: 

June 27, 2011.

Influenza Vaccine: Federal Investments in Alternative Technologies and 

Challenges to Development and Licensure. GAO-11-435. Washington, 

D.C.: June 27, 2011.

National Preparedness: DHS and HHS Can Further Strengthen 

Coordination for Chemical, Biological, Radiological, and Nuclear Risk 

Assessments. GAO-11-606. Washington, D.C.: June 21, 2011.

Public Health Preparedness: Developing and Acquiring Medical 

Countermeasures Against Chemical, Biological, Radiological, and 

Nuclear Agents. GAO-11-567T. Washington, D.C.: April 13, 2011.

Combating Nuclear Terrorism: Actions Needed to Better Prepare to 

Recover from Possible Attacks Using Radiological or Nuclear Materials. 

GAO-10-204. Washington, D.C.: January 29, 2010.

Related GAO Products

(291142)
The Government Accountability Office, the audit, evaluation, and 

investigative arm of Congress, exists to support Congress in meeting its 

constitutional responsibilities and to help improve the performance and 

accountability of the federal government for the American people. GAO 

examines the use of public funds; evaluates federal programs and 

policies; and provides analyses, recommendations, and other assistance 

to help Congress make informed oversight, policy, and funding decisions. 

GAO’s commitment to good government is reflected in its core values of 

accountability, integrity, and reliability.

The fastest and easiest way to obtain copies of GAO documents at no 

cost is through GAO’s website (http://www.gao.gov). Each weekday 

afternoon, GAO posts on its website newly released reports, testimony, 

and correspondence. To have GAO e-mail you a list of newly posted 

products, go to http://www.gao.gov and select “E-mail Updates.”

The price of each GAO publication reflects GAO’s actual cost of 

production and distribution and depends on the number of pages in the 

publication and whether the publication is printed in color or black and 

white. Pricing and ordering information is posted on GAO’s website, 

http://www.gao.gov/ordering.htm. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 

TDD (202) 512-2537.

Orders may be paid for using American Express, Discover Card, 

MasterCard, Visa, check, or money order. Call for additional information.

Connect with GAO on Facebook, Flickr, Twitter, and YouTube. 

Subscribe to our RSS Feeds or E-mail Updates. Listen to our Podcasts. 

Visit GAO on the web at www.gao.gov. 

Contact:

Website: http://www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470

Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-

4400, U.S. Government Accountability Office, 441 G Street NW, Room 

7125, Washington, DC 20548

Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, DC 20548

GAO’s Mission

Obtaining Copies of 

GAO Reports and 

Testimony

Order by Phone

Connect with GAO

To Report Fraud, 

Waste, and Abuse in 

Federal Programs

Congressional 

Relations

Public Affairs

Please Print on Recycled Paper.